Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Not Recruiting

Trial ID: NCT00110019


This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.

Official Title

A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in Patients With Unresectable Locally Advanced or Stage IV Melanoma

Stanford Investigator(s)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


Inclusion Criteria:

   - Histological or cytological confirmed melanoma that is metastatic or unresectable;
   patients must have a history of cutaneous, mucosal or unknown primary site

   - Patients who have received prior systemic cytotoxic chemotherapy for treatment of
   melanoma are ineligible; the following groups are eligible with regard to prior
   systemic therapy either in the adjuvant or metastatic disease setting:

      - No prior therapy

      - Immunotherapy consisting of interferon, interleukin-2, granulocyte macrophage
      colony-stimulating factor (GM-CSF) or vaccine

      - One prior investigational therapy (cannot be chemotherapy or an inhibitor of rat
      sarcoma [Ras], serine/threonine kinase [Raf], or mitogen-activated protein kinase
      kinase [MEK])

         - NOTE: Chemotherapy given via isolated limb perfusion is allowed

   - Prior radiation therapy is allowed; however, if radiation has been administered to a
   lesion, there must be radiographic evidence of progression of that lesion in order for
   that lesion to constitute measurable disease or to be included in the measured target

   - All sites of disease must be evaluated within 4 weeks of registration; patients must
   have measurable disease as defined by Response Evaluation Criteria in Solid Tumors

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

   - White blood count >= 3,000/mm^3

   - Absolute granulocyte count >= 1,500/mm^3

   - Platelet count >= 100,000/mm^3

   - Serum creatinine =< 2.0 x upper limit of normal (ULN) or serum creatinine clearance
   (CrCl) >= 40 ml/min (neither drug is cleared by the kidney)

   - Total bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert's disease)

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5.0
   ULN in the presence of liver metastases)

   - International normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT)
   within normal limits (patients who are on therapeutic anticoagulation with warfarin
   should have documentation of a normal prothrombin time [PT]/PTT prior to initiating
   that therapy)

   - Patients must not have ocular melanoma

   - Patients must have discontinued immunotherapy or radiation therapy at least 4 weeks
   prior to initiation of treatment and recovered from adverse events due to those agents

   - Patients must not receive any other investigational agents during the period on study
   or the four weeks prior to initiation of treatment

   - Patients must not have a history or clinical evidence of brain metastasis; patients
   must be evaluated with a head magnetic resonance imaging (MRI) within 4 weeks prior to

   - Patients must not have other current malignancies, other than basal cell skin cancer,
   squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in
   situ of the breast; patients with other malignancies are eligible if they have been
   continuously disease-free for >= 5 years prior to the time of randomization

   - Patients must not have any evidence of bleeding diathesis

   - Patients must not have a serious intercurrent illness including, but not limited to,
   ongoing or active infection requiring parenteral antibiotics, clinically significant
   cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction,
   unstable angina), New York Heart Association grade II or greater congestive heart
   failure, serious cardiac arrhythmia requiring medication, or grade II or greater
   peripheral vascular disease within 1 year prior to study entry, or psychiatric
   illness/social situations that would limit compliance with study requirements

   - Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs
   (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's Wort

   - Women must not be pregnant or breast-feeding

   - All females of childbearing potential must have a blood test or urine study within 4
   weeks prior to registration to rule out pregnancy

   - Women of child-bearing potential and men must agree to use adequate contraception
   (hormonal or barrier method of birth control; abstinence) prior to study entry and for
   the duration of study participation; should a woman become pregnant while
   participating in this study, she should inform her treating physician immediately; if
   a man impregnates a woman while participating in this study, he should inform his
   treating physician immediately as well

   - Human immunodeficiency virus (HIV)-positive patients are excluded from the study


other: placebo

other: pharmacological study

other: laboratory biomarker analysis

drug: carboplatin

drug: paclitaxel

drug: sorafenib tosylate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sunil Reddy

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